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FDA Approves Use of Menactra® Vaccine for Booster Immunization Against Potentially Deadly Disease

Approval aligns with Centers for Disease Control and Prevention's recommendations for meningococcal vaccination

Sep 8, 2014

SWIFTWATER, Pa., Sept. 8, 2014 /PRNewswire-USNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) approved use of Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] for booster vaccination against meningococcal disease in persons 15 years through 55 years of age.

Meningococcal disease, which includes meningococcal meningitis, is a serious bacterial infection that strikes approximately 800 to 1,200 Americans each year.1 Although rare, it can result in severe, permanent disabilities and death.2 Of those who survive, up to one in five are left with serious medical problems, which include amputation of arms, legs, fingers, or toes; neurologic damage; and deafness.1,2

The Centers for Disease Control and Prevention (CDC) recommends routine administration of meningococcal conjugate vaccine to adolescents aged 11 through 18 years.2 Specifically, the CDC recommends persons receive one dose of vaccine at age 11 or 12 years, followed by a second (i.e. booster) vaccination at age 16 years, to help protect teens and young adults during the period when they are at increased risk of contracting meningococcal disease. It is important that health care providers and parents be aware of the need for a booster dose, as current data suggest that vaccine protection wanes in most teens within five years after the primary vaccination.1

Despite these recommendations, results from CDC's recently published 2013 National Immunization Survey-Teen (NIS-Teen) showed that the second-dose completion rate for meningococcal conjugate vaccine was only an estimated 29.6 percent among 17-year-olds, compared to a single-dose completion rate of 77.8 percent among 13-through 17-year-olds.3

"The FDA's approval of the Menactra booster vaccination gives health care providers the option to use a meningococcal conjugate vaccine that is approved for both primary and booster immunization, which aligns with the CDC's recommendations for preventing cases of meningococcal meningitis," said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "With this approval, we hope health care providers are reminded to talk to their teen patients and their parents about the CDC's recommendations, ultimately helping to improve booster immunization rates for teens across the country."

Teens are at an increased risk of meningococcal disease due to common everyday activities such as kissing, sharing utensils and water bottles and living in close quarters, such as a college dormitory.4,5,6,7

This FDA approval of Menactra was based on results of an open-label trial that evaluated the safety and immunogenicity of a booster dose of Menactra vaccine among persons who received Menactra vaccine 4 to 6 years earlier. The most common adverse events reported after the booster dose were injection-site pain and myalgia. Overall rates of solicited injection-site reactions and solicited systemic reactions were similar to those observed in adolescents and adults after a single dose of Menactra vaccine.  

Menactra vaccine was approved by the FDA in January 2005, making it the first quadrivalent conjugate vaccine licensed in the United States for active immunization against meningococcal disease caused by the serogroups contained in the vaccine (A, C, Y and W-135). 

For persons for whom a primary vaccination is recommended, Menactra vaccine should be given as a 2-dose series, administered 3 months apart, for children 9 months through 23 months of age and as a single dose for persons 2 years through 55 years of age.

About Meningococcal Disease and Meningococcal Meningitis
Meningococcal disease is a bacterial infection caused by Neisseria meningitidis and includes meningitis, bacteremia (severe blood infection) and pneumonia.1 Approximately 50 percent of meningococcal cases are meningococcal meningitis.1 Meningococcal meningitis is a serious bacterial infection characterized by swelling of the tissues around the brain and spinal cord.2 Meningococcal meningitis develops rapidly and can claim the life of an otherwise healthy person in as little as one day after the first symptoms appear.8

About Menactra Vaccine
Indication
Menactra vaccine is given to people 9 months through 55 years of age to help prevent invasive meningococcal disease (including meningitis) caused by serogroups A, C, Y, and W-135 of meningococcal bacteria. Menactra vaccine does not prevent serogroup B disease.

Safety Information
Side effects to Menactra vaccine include pain, redness, swelling at the injection site; headache and tiredness. In infants, side effects include irritability, abnormal crying, drowsiness, and loss of appetite. Other side effects may occur.

Menactra vaccine is contraindicated in persons with a known hypersensitivity (e.g., anaphylaxis) to any component of the vaccine. Persons previously diagnosed with Guillain-Barré syndrome (GBS) may be at increased risk of GBS following receipt of Menactra vaccine. The decision to give Menactra vaccine should be based on careful consideration of the potential benefits and risks. GBS has been reported in temporal relationship following administration of Menactra vaccine. Vaccination with Menactra vaccine may not protect all individuals.

For more information about Menactra vaccine, please see the full Prescribing Information available at www.sanofipasteur.us or www.vaccineshoppe.com

About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

References:                                                        

[1] Centers for Disease Control and Prevention (CDC). Prevention and control of meningococcal disease – recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report (MMWR). 2013;62(2):1-13. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6202a1.htm. Accessed September 2014.

[2] Centers for Disease Control and Prevention (CDC). Meningococcal Vaccines: What You Need To Know. http://www.cdc.gov/vaccines/hcp/vis/vis-statements/mening.pdf. Accessed March 24, 2014.

[3] Center for Disease Control and Prevention (CDC). National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2013 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6329a4.htm?s_cid=mm6329a4_w.

[4]  Stephens DS, Greenwood B, Brandtzaeg P. Epidemic meningitis, meningococcaemia, and Neisseria meningitidis. Lancet. 2007;369(9580):2199.

[5] Centers for Disease Control and Prevention (CDC). Meningococcal Disease. About: Causes and Transmission. http://www.cdc.gov/meningococcal/about/causes-transmission.html. Accessed March 24, 2014.

[6] Swanson JR. Infectious disease in the strength and conditioning facility. Strength and Conditioning Journal. 2006;28(6):76-80.

[7] Rachael T, Schubert K, Hellenbrand W, et al. Risk of transmitting meningococcal infection by transient contact on aircraft and other transport. Epidemiology Infection. 2009;137(8):1057-61.

[8] World Health Organization. Meningococcal Meningitis. http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed July 22, 2014.

SOURCE Sanofi Pasteur

For further information: Global Media Relations, Alain Bernal, T. +33-4-37-37-50-38, alain.bernal@sanofipasteur.com, www.sanofipasteur.com; U.S./Country Media Relations, Marisol Peron, T. +1-570-957-0717, mediaUS@sanofipasteur.com, www.sanofipasteur.us